The EU MDR set new perspectives on the European healthcare market, with enhanced patient safety measures and more stringent regulatory oversight of industry operations.

While manufacturers recognize the European Commission’s efforts in establishing a safer market, many areas of the new rules challenge the industry, creating confusion as to precisely what changes the MDR require and the best way to implement regulatory mandates.

By comparing notified bodies’ and regulatory affairs executives’ perspectives, practical advice and insight will be shared on which provisions to address first and why, to ultimately reflect compliance in updated and new corporate strategies.